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Regulatory

Latest Headlines

Latest Headlines

BG Medicine gets FDA blessing for automated chronic heart failure test

BG Medicine got an FDA nod for an automated version of its test for chronic heart failure, a win for the company as it charges ahead with development after laying out some cost-cutting measures last fall.

Theranos grabs FDA approval for finger-stick herpes test

Silicon Valley startup Theranos snagged FDA approval for its finger-stick test for herpes, a feather in the company's cap as it looks to expand the reach for its product and challenge its rivals' business models.

Sanofi and Gilead set sail to Japan with new approvals for Toujeo, Harvoni

Drugmakers are ready to pounce on Japan's rapidly growing pharmaceutical market, and Sanofi and Gilead are hopping on the bandwagon with a fresh crop of approvals. Sanofi got a regulatory OK for diabetes newcomer Toujeo, while Gilead got a greenlight for hep C combo med Harvoni in the country.

Theranos nabs FDA clearance for finger-stick herpes test

Theranos moved a step closer to its vision of providing cheap and rapid point-of-care diagnoses based on a few drops of blood thanks to its first FDA clearance. The agency said the Theranos System can be used to detect herpes simplex virus 1.

Alibaba Health plans wider online sales push in China as competition grows

Alibaba Group Holdings aims for a controlling stake in HK-listed Alibaba Health Information Technology as it seeks to grow in a still-fragmented market in China for online drug sales that increasingly looks like a tough nut to crack as competition grows and regulatory approvals drag, the South China Morning Post reports.

Japan's Otsuka eyes MDR-TB drug nod in Indonesia in team with Nipro diagnostic effort

Otsuka Pharmaceutical has applied to sell multidrug-resistant tuberculosis drug Delamanid in Indonesia and join hands with fellow Japanese firm Nipro to ramp up diagnostic efforts, the Nikkei Asian Review reports.

Takeda's Hasegawa out as JPMA VP after firm called to task on Blopress

Takeda Pharmaceutical Chairman Yasuchika Hasegawa was removed as vice president by the Japan Pharmaceutical Manufacturers Association, according to an updated leadership list that was confirmed by a company spokesman.

Congressman pushes to unshackle pharma on social media

A congressman is taking aim at perceived flaws in FDA's long-awaited, much-discussed guidance on the use of Twitter.

USDA amends rules to allow vets to make custom vaccines in their offices

The U.S. Department of Agriculture has amended its rules to allow veterinarians to make vaccines in their offices for individual clients, as long as compounds aren't contracted out to unlicensed manufacturers.

UPDATED: Vertex wins a crucial FDA nod for its cystic fibrosis combo, prices at $259,000

Vertex Pharmaceuticals won the FDA's blessing to market a new combination therapy for cystic fibrosis, clearing the way for a drug key to the company's future as it moves away from antiviral treatments.